Clearance Summary
RAPID RHINO-ANTERIOR 90MM, MODEL RR-A 90, RAPID RHINO-POSTERIOR 100MM, MODEL RR-P 100 received FDA 510(k) clearance under submission number K000108, sponsored by Bhk Holding. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ear, Nose, Throat review panel. The statutory decision date of record is 2000-05-23.
- Submission: K000108
- Applicant / Sponsor: Bhk Holding
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class I
- Regulation citation: 21 CFR 874.4100
- Decision date: 2000-05-23
Classification & Regulation
This clearance is catalogued under FDA product code EMX and 21 CFR 874.4100, within the Ear, Nose, Throat review panel as a Class I device.